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The purpose of this study is to investigate the efficacy of Enhanced External Counterpulsation (EECP) therapy on ventricular function in patients with coronary heart disease
Patients with coronary heart disease will be randomized into two groups:
standard medical treatment and standard medical treatment plus EECP intervention. Ventricular structure and function will be measured and compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced External Counterpulsation | Experimental | Experimental: Enhanced External Counterpulsation (EECP) intervention on top of guideline- driven standard medical therapy for coronary heart disease |
|
| Control | Active Comparator | Guideline- driven standard medical therapy for 7 weeks without Enhanced External Counterpulsation intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Enhanced External Counterpulsation | Device | Enhanced External Counterpulsation (EECP) is a technique for assisting the circulation by decreasing the afterload of the left ventricle and augmenting the diastolic pressure externally by applying a negative pressure to the lower extremities during cardiac systole. EECP therapy has been approved by the United States Food and Drug Administration (FDA) for the treatment of refractory angina and heart failure. Administration of 35-36 hours EECP therapy over a 7 week period, one hour session every working day. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in heart function | Change from baseline in heart function assessed by trans- thoracic echocardiography at 7 weeks | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cardiac chamber diameter | Change from baseline in cardiac chamber diameterat 7 weeks | 7 weeks |
| Change in ventricular wall thickness | Change from baseline in ventricular wall thickness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yan Zhang, M. D. | First Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Zhensheng Zheng, M. D. | First Affiliated Hospital, Sun Yat-Sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Sun Yat- sen University | Guangzhou | Guangdong | 510080 | China |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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|
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| Standard medical therapy | Drug | Guideline- driven standard medical treatment for 7 weeks |
|
|
| 7 weeks |